Over 5 million people die from massive haemorrhage every year worldwide. The major reason for the death rate being so high is that there are limited options for treating a haemorrhage and the massive bleeding associated with it. In fact, it is estimated that 10-20 % of haemorrhage patients would survive with better treatment and bleeding control. According to research conducted over the past decade, the key to controlling haemorrhage-related bleeding is to improve coagulation, the body’s natural mechanism for bleeding control. To do so, the EU-funded ClearPlasma project is developing an innovative filtration system that treats massive bleeding by improving the coagulation properties of human plasma. “With the ClearPlasma device, we aim to save the lives of millions of bleeding patients around the world,” says Zeev Dvashi, ClearPlasma project coordinator and CEO at PlasFree, the project’s host.
To reduce massive bleeding, ClearPlasma promotes haemostasis by enhancing coagulation, the process of changing blood from a liquid to clots. Haemostasis uses coagulated blood to keep non-coagulated blood within a damaged blood vessel, thus stopping the bleeding. ClearPlasma improves this natural process by extracting plasminogen, an important protein responsible for dissolving blood clots. During this project, PlasFree conducted the validations needed to bring its device to market – a process that wasn’t always as straightforward as planned. For example, because plasma filtration can affect other coagulation factors, researchers had to develop a filtration system that could absorb plasminogen without affecting the composition of the plasma itself. “We overcame this challenge by developing a linker that binds the plasminogen without affecting any of the other proteins,” explains Dvashi. With this linker in place, the device moved into pre-clinical testing in mouse and swine laceration models. “Our pre-clinical tests successfully demonstrated that ClearPlasma can reduce bleeding by 55 % compared to a regular plasma transfusion,” adds Dvashi.
A key player
According to Dvashi, the project succeeded in advancing the ClearPlasma device from concept to clinical trial in less than 3 years. As a result, it is well-positioned to be a key player in managing massive haemorrhage. “We are proud to have developed a new device that can improve the treatment of massive-bleeding patients with minimal interference to the clinical set-up,” concludes Dvashi. “Once approved for clinical use, ClearPlasma will enhance haemostasis, reduce bleeding time and volume, and help save lives.” PlasFree is currently conducting clinical studies to demonstrate the device’s safety and efficacy in upper gastrointestinal bleeding patients. It will then seek CE-mark status and FDA approval.
ClearPlasma, massive bleeding, medical device, plasma, haemorrhage, bleeding control, blood clots